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NCT05956158

RISE: A Remote Study of Insomnia Treatment in Crohn's Disease

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Dartmouth-Hitchcock Medical Center
~83 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Behavioral TreatmentSleep Education Treatment

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of the intervention as measured by attrition rate over time
Measured over Baseline, 8 weeks, 21 weeks, and 34 weeks
+6 more outcomes measured

Conditions

Insomnia
Crohn Disease

Explore related trials

Crohn DiseaseInsomnia

Where it's being run

1 sites across 1 states
New Hampshire1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Mild to moderate CD based on PRO-3 \& 50% with objective evidence of active disease
Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes
Stability of sleep \& CD meds for ≥ 3 months
Access to internet or cell phone service sufficient for telehealth

Exclusion

PHQ-9 depression score ≥ 15
GAD-7 anxiety score ≥ 15
Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
Current alcohol or substance abuse
Current opioid use for pain control
Current systemic corticosteroid use
Current pregnancy or nursing
Ileostomy or colostomy
Diagnosis of seizure disorder
Diagnosis of sleep apnea or positive WatchPAT screen
Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
Night shift, rotating shift work, or frequent travel outside of time zone

What this trial measures

  • Feasibility of the intervention as measured by attrition rate over timeBaseline, 8 weeks, 21 weeks, and 34 weeks

    Attrition rate will be based on the percentage of participants who have dropped out of the trial at different time points.

  • Feasibility of the intervention as measured by recruitment rate over timeFrom study initiation until we are no longer actively recruiting (approximately 24 months)

    Recruitment rate will be based on the number of participants who are recruited into the trial per month.

  • Feasibility of the intervention as measured by assessment completion at multiple time pointsBaseline, 8 weeks, 21 weeks, and 34 weeks

    Assessment completion rate will be based on the percentage of participants who complete all the required questionnaires and tasks at each time point.

  • Feasibility of the intervention as measured by qualitative interviews8 weeks and 34 weeks

    Feasibility will be based on interview-derived themes related to barriers and facilitators to study engagement. Data will be collected at two time points to ensure completeness of themes.

  • Acceptability of the intervention as measured by visit completion8 weeks

    Visit completion will be based the number of visits (out of 5) completed by each participant.

  • Treatment acceptability questionnaire score1 week

    The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability.

  • Acceptability of the intervention as measured by qualitative interviews8 weeks

    Acceptability will be based on interview-derived themes related to aspects of the intervention that participants found helpful and unhelpful.